Geoffrois, Lionnel
Harlé, Alexandre
Sahki, Nassim
Sikanja, Aleksandra
Granel-Brocard, Florence
Hervieu, Alice
Mortier, Laurent
Jeudy, Géraldine
Michel, Catherine
Nardin, Charlée
Huin-Schohn, Cécile
Merlin, Jean-Louis
Funding for this research was provided by:
Direction Générale de l’offre de Soins,France (PHRCI-2021-86)
Article History
Received: 21 April 2023
Accepted: 30 May 2023
First Online: 16 June 2023
Declarations
:
: <b>Regulatory requirements</b>The study will be performed in compliance with:• The ethical principles as outlined in the latest version of the Declaration of Helsinki;• Good Clinical Practice, as defined in the version dated 24 November 2005 from the International Conference on Harmonization (ICH-E6);• French National legislation on privacy of personal data (“Informatique et Libertés” law number 78–17 dated 6 January 1978, modified by law number 2004–801 dated 6 August 2004) relating to the protection of privacy in the management of personal data;• French Bioethics law number 2004–800 dated 6 August 2004;• French Decree number 2016–1537 dated 16 November 2016 relating to research involving human subjects;• French decree dated 7 May 2017 listing the types of research mentioned in paragraph 2 of article L. 1121–1 of the code of public health;• French decree dated 9 May 2017 modifying certain regulatory dispositions relating to research involving human subjects.<b>Ethics committee, competent authority, CNIL (national data privacy commission)</b>Prior to initiating any research involving human subjects, the sponsor is required to submit the project for approval to an Ethics Committee with competence for the location in which the lead investigator practices, and for information to the French health products safety agency (ANSM). The sponsor will submit a request for approval to the competent authority for the conduct of an interventional research study with minimal risks and constraints.Requests for substantial modifications to the initial protocol will also be sent by the sponsor to the Ethics Committee for approval, and to the competent authority for information.This study is performed in compliance with the reference methodology MR-001 of the CNIL (national data privacy commission). The promoter, Institut de Cancerologie de Lorraine, has declared to be in conformity with the MR-001 methodology for the treatment of patients’ personal data for the purposes of biomedical research (declaration number 2203858 dated 24 July 2018).Patient information and informed consent from the patient must be handled in accordance with the French regulation. Prior to the participation of a patient in the trial, this patient will be informed both verbally and in writing about the objectives of the trial, its methods, anticipated benefits and potential risks and the discomfort to which they may be exposed. The informed consent form for study and ancillaries studies, must be personally dated and signed by the patient and investigator.The present protocol was approved by the Ethics Committee (Comité de Protection des Personnes Sud Est V) on 13/12/2022 under the reference number SI RIPH 2G: 22.04019.000105, and is registered on ClinicalTrials.gov with the number NCT04866680, and in ID-RCB with the number 2022-A01904-39.The first patient was included on February 6th, 2023.
: Not applicable.
: JLM received honoraria for consulting and financial supports for participation to meetings by Novartis, Bristol Myers Squibb, MSD, Pierre Fabre, Roche.JLM and AHa received financial research grants from Novartis.AHa received honoraria for consulting and financial supports for participation to meetings by Biocartis, BioRad, BMS, MSD, Novartis, Pierre Fabre, Roche, Sophia Genetics.GJ received honoria for consulting and financial supports for participation to mmeetings by Novartis, BMS, MSD, Pierre Fabre.FGB received honoraria for consulting and financial supports for participation to meetings by Novartis, Bristol Myers Squibb, MSD, Pierre Fabre, Sun Pharma.CM received honoraria for consulting and financial supports for participation to meetings by BMS, Novartis, Pierre Fabre,.CN received honoraria for consulting and financial supports for participation to meetings by Novartis, Bristol Myers Squibb, MSD, Pierre Fabre.LM received honoraria for consulting and financial supports for participation to meetings by Novartis, Bristol Myers Squibb, MSD, Merck, Pierre Fabre.AHe received honoraria for consulting by Novartis, Pierre Fabre, MSD.All other authors declared that they have no competing interests.